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L'essai clinique NCT06377254 (CHAIN) pour Comportement sédentaire, Syndrome métabolique, Déclin cognitif lié à l'âge, Sarcopénie liée à l'âge est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
Multi-organ Responses to CHronic Physical Activity and INactivity (CHAIN)
Persistent physical inactivity is thought to be a key contributing factor to the risk of poor health and functional decline occurring in middle-aged and older adults. It is therefore concerning that most middle-aged adults spend >8hrs/day being sedentary, with average step count of 3000-4000 steps/day.
To be able to holistically assess the effectiveness of future strategies to address age-related decline in health, and devise public health messages to help individuals reach older age in better health, it is essential that the complex physiological effects that activity and inactivity have across biological systems are characterised.
The goal of this intervention study is to compare the impact of physical activity and inactivity on body functioning. Twenty moderately active participants will decrease their physical activity for three months to match the average amount carried out by middle-aged people in the UK. They will then undertake 3-months of reconditioning training to restore their fitness. In addition, twenty sedentary participants will increase their physical activity to UK recommended levels for six months.
Before and at points during the intervention period, participants will be asked to make some measurements at home and attend the University of Nottingham to have multiple assessments made. These include;
- fitness, muscle strength and function tests,
- completion of questionnaires and computer-based brain puzzles
- having muscle and fat tissue biopsies and blood samples taken.
- The study also involves having MRI scans.
This 5-year study will commence in January 2024, with participant recruitment starting in March 2024 and finishing in May 2027.
In addition, twenty participants who currently have low physical activity levels will be asked to increase their physical activity to UK recommended levels by attending the Medical School at Queen's Medical Centre, Nottingham, three times a week for six months to undertake a supervised exercise program.
Before and during the 6-month period (at weeks 6, 12, 18 and 24) participants will be asked to make some measurements at home (physical activity levels, dietary intake) and attend the University of Nottingham over 4 days to have multiple assessments made. These include: height; weight; body composition (body fat and lean tissue); blood pressure; fitness, muscle strength and function; sleep quality, quality of life and wellbeing (questionnaires). The rate of muscle protein breakdown and muscle protein synthesis, blood sugar regulation, and biochemistry of the blood, fat tissue and muscles will be assessed, and to enable this muscle and fat tissue biopsies will be collected and blood samples taken. The study also involves having MRI scans to study the structure and function of the brain and heart, and to determine liver and muscle fat content.
Concurrent Multi-organ Responses to CHronic Physical Activity and INactivity Intervention, to Increase Research Discovery in Human Health and Wellbeing
- CHAIN
- BB/X015173/1
middle-age
Physical inactivity
overweight
lifestyle
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalInactivity Participants in this group will reduce their physical activity (increase sitting time to 7hrs/day and decrease step count to \<4500/day) for 3 months, then increase their activity for 3 months, through attending 3x 45 min supervised exercise sessions/week. | Decreased Physical Activity Physical activity levels will be decreased |
ExpérimentalActivity Participants in this group will have moderate intensity physical activity levels increased for 6 months, through attending 3x 45 min supervised exercise sessions/week. | Increased Physical Activity Physical activity levels will be increased |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Change in Cardiorespiratory fitness (VO2 max) | change in maximal oxygen uptake (continuous incremental bicycle ergometer exercise test with on-line gas analysis) measured every 6 weeks | 12 weeks |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Change in Isometric leg strength | Change in Isometric leg strength measured every 6 weeks using CYBEX dynamometer | 24 weeks |
Change in time to leg fatigue | Change in time taken to induce muscle fatigue measured every 6 weeks using isokinetic knee extensions on a CYBEX dynamometer | 24 weeks |
Change in incremental area under the curve (iAUC) for blood glucose concentration | Change in 180 minute blood glucose concentration incremental area under the curve measured every 6 weeks during an oral glucose tolerance test. | 24 weeks |
Change in iAUC for serum insulin concentration | Change in 180-minute serum insulin concentration incremental area under the curve measured every 6 weeks during an oral glucose tolerance test | 24 weeks |
Change in fasting glucose oxidation rate | Change in glucose oxidation rate (when fasted), measured every 6 weeks using ventilated hood indirect calorimetry | 24 weeks |
Change in 'fed' glucose oxidation rate | Change in glucose oxidation rate (in the insulin-stimulated 'fed' state), measured every 6 weeks using ventilated hood indirect calorimetry during an oral glucose tolerance test | 24 weeks |
Change in Short Form Health Survey (SF36) Questionnaire aggregated normalised 'physical' score | Change in 'SF36' Questionnaire aggregated 'physical' score (normalised to UK population) calculated according to standard procedures (min 0, max 100), with higher score indicating better physical wellbeing measured every 6 weeks | 24 weeks |
Change in Short Form Health Survey (SF36) Questionnaire aggregated and normalised 'mental' score | Change in 'SF36' Questionnaire aggregated 'mental' score (normalised to UK population) calculated according to standard procedures (min 0, max 100), with higher score indicating better mental wellbeing, measured every 6 weeks | 24 weeks |
Change in World Health Organisation Quality of Life (WHOQoL) score | Change in World Health Organisation Quality of Life Score (measured using the WHOQoL-Bref questionnaire every 6 weeks), (min score 0, max 100), with higher score indicating a better state of health. | 24 weeks |
Change in Pittsburgh Sleep Quality Index (PSQI) | Change in PSQI score (min score 0, max 21), measured every 6 weeks, with higher score indicating poorer sleep quality | 24 weeks |
Change in Stroop test; % Accuracy | Change in the percentage of accurate responses, measured every 6 weeks, with higher score indicating better cognitive performance. Minimum value 0%, maximum value 100% | 24 weeks |
Change in Stroop test; reaction time | Change in the reaction time for responses, measured every 6 weeks, with higher score indicating slower cognitive performance. No minimum or maximum value defined. | 24 weeks |
Change in four-choice reaction time test; % Accuracy | Change in the percentage of accurate responses, measured every 6 weeks, with higher score indicating better cognitive performance. Minimum value 0%, maximum value 100% | 24 weeks |
Change in four-choice reaction time test; reaction time | Change in the reaction time for responses, measured every 6 weeks, with higher score indicating slower cognitive performance. No minimum or maximum value defined. | 24 weeks |
Change in card sort test; % Accuracy | Change in the percentage of accurate responses, measured every 6 weeks, with higher score indicating better cognitive performance. Minimum value 0%, maximum value 100% | 24 weeks |
Change in card sort test; reaction time | Change in the reaction time for responses, measured every 6 weeks, with higher score indicating slower cognitive performance. No minimum or maximum value defined. | 24 weeks |
Change in Logical reasoning test; % accuracy | Change in the accuracy of responses, measured every 6 weeks, with higher score indicating better cognitive performance. Minimum value 0%, maximum value 100% | 24 weeks |
Change in Logical reasoning test; reaction time | Change in the reaction time for responses, measured every 6 weeks, with higher score indicating slower cognitive performance. No minimum or maximum value defined. | 24 weeks |
Change in serial subtractions test; number of responses in 2 minutes | Change in the number of responses, measured every 6 weeks, with higher score indicating better cognitive performance. minimum number is 0, maximum number is variable dependent on starting value (800-999; randomly selected by computer program) and speed of response. | 24 weeks |
Change in Corsi blocks test; score | Change in the test score, measured every 6 weeks, with higher score indicating better cognitive performance.Minimum score is 0 and maximum is 15. | 24 weeks |
Change in Muscle protein synthesis rate | Muscle synthesis protein rate calculated from deuterium incorporation into muscle tissue | 24 weeks |
Change in Muscle protein breakdown rate | Muscle protein breakdown rate calculated every 6 weeks using 3-methylhistidine tracer | 24 weeks |
Change in whole body fat volumes | Change in the amount of fat within the body, measured every 6 weeks using magnetic resonance imaging (MRI) | 24 weeks |
Change in liver fat volumes | Change in the amount of fat within the liver, measured every 6 weeks using magnetic resonance imaging (MRI) | 24 weeks |
Change in thigh muscle fat volumes | Change in the amount of fat within the vastus lateralis thigh muscle, measured every 6 weeks using magnetic resonance imaging (MRI) | 24 weeks |
Change in whole body muscle volumes | Change in the amount of muscle within the body, measured every 6 weeks using magnetic resonance imaging (MRI) | 24 weeks |
Change in muscle phosphocreatine synthesis rate | Change in the rate of phosphocreatine synthesis, measured every 6 weeks using magnetic resonance spectroscopy | 24 weeks |
Change in cerebral volume | Change in the volume of brain tissue, measured every 6 weeks using magnetic resonance imaging (MRI) | 24 weeks |
Change in cortical thickness | Change in the thickness of the brain cortex, measured every 6 weeks using magnetic resonance imaging (MRI) | 24 weeks |
Change in plasma metabolome | change in untargeted plasma metabolome profile measured every 6 weeks | 24 weeks |
- Group 1 ('non-sedentary') self-reporting <6 sedentary hrs/day, not actively involved in exercise training or a regular physical activity regimen (>8,000 steps/day).
- Group 2 ('sedentary') self-reporting ≥8 waking hrs/day in sedentary activities and/or ≤5,000 steps/day.
- Aged 55-65y.
- Overweight (BMI 25-35 kg/m2).
- Waist circumference ≥94cm (males) and ≥80cm (females).
- Willing to alter physical activity levels as instructed for 6 months
- Without neurological or psychiatric diseases, motor or cognitive restrictions
- Ability to give informed consent
- Regular medication use that could interfere with measures
- A history, or evidence, of chronic cardiovascular, metabolic, musculoskeletal, renal or respiratory diseases.
- Experiencing 'long-COVID', inflammatory bowel disease or malignancy.
- Uncontrolled hypertension. Stage 1 hypertension (BP ≤160/100mmHg) with no other signs of cardiovascular disease, and blood pressure (BP) managed by routine medication will not be an exclusion.
- People employed in jobs that would preclude reducing step count and night-shift workers.
- Females who are pre/peri-menopausal, but stable on hormone replacement therapy is accepted (due to effect of oestrogen fluctuations on primary outcomes and the longitudinal study design).
- Contraindications for MRI.
- Allergy or sensitivity to local anaesthesia, or dressing adhesive
Notts